FDA Gene Therapy Adverse Event Tracking System Will Have Broad Scope
Executive Summary
FDA's Gene Therapy Patient Tracking System will attempt to track the full range of adverse events in patients enrolled in gene transfer studies
You may also be interested in...
CBER Gene Therapy Office To Be Established By Oct. 1
CBER's Office of Cells, Tissues & Gene Therapy will address the "evolution" of scientific and regulatory issues, FDA Center for Biologics Evaluation & Research Director Kathryn Zoon, PhD, said May 29
Gene Therapy 15-Year Follow-Up In Four AE Categories Suggested By Cmte.
Gene therapy clinical trial subjects should be followed in four adverse event categories for 15 years, FDA's Biological Response Modifiers Advisory Committee recommended Oct. 24.
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011